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510(k) Data Aggregation
(257 days)
Guangzhou Hehong Biotech Co., Ltd.
The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.
The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are intended for use in closed vitrification procedures to contain and maintain human oocytes (MI), 4-8 cell embryos, and blastocyst stage embryos, and they are intended for use in professional healthcare facilities. The subject devices are for single use, disposable and supplied sterile.
The Minvitro® Vitrification Straws (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are all composed of a cap with a balancing head, a handle, a carrier sheet with a fine tip at the end. The oocytes or embryos are loaded on the carrier sheet, and in which, the fine tip of carrier sheet is flat with a triangular-shaped area for oocyte/embryo loading. The subject devices are sterilized using ethylene oxide (EO) to a sterilization assurance level of 106, are singleuse, and have a 2-year shelf-life.
The subject devices are available in five colors: MVT-VSNR. MVT-VSNY. MVT-VSNB. MVT-VSNG, and MVT-VSNP corresponding to Red, Yellow, Blue, Green, and Purple, respectively, all identical in size.
The Minvitro® Vitrification Straw (K241454) is a cryopreservation storage device. It underwent non-clinical performance testing to demonstrate its substantial equivalence to the predicate device, Cryotop® US-flash (K181469).
Here's an overview of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criterion | Reported Device Performance (Minvitro® Vitrification Straw) |
|---|---|---|
| Sterilization | SAL of 10⁻⁶ (EO process) | Validated in accordance with ISO 11135:2014, ISO 11607-1-2006/Amd 1-2014, ISO 11607-2-2006/Amd 1-2014, ISO 11737-1:2018, ISO 11737-2:2009, ISO 11138-2:2017, ISO 10993-7:2008/Cor 1-2009. |
| Endotoxin | ≤ 0.5 EU/device | , and FDA guidance for MEA define the acceptable parameters and outcomes for device performance. |
- Predicate device's specifications: For tests like cooling/warming rates, the predicate device's performance characteristics served as a benchmark for comparison.
- Pre-defined biological endpoints: In the case of the Mouse Embryo Assay, the development of embryos to the blastocyst stage at a certain percentage defines the biological "ground truth" for toxicity and suitability.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the context of algorithm development. The tests described are for a physical medical device.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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